Clinical Study of FRC Implant to Treat Skull Bone Defects

Not Applicable

• Conditions: Orbital Base Fracture; Cranial Bone Defect
• Interventions: Device: FRC implant reconstruction

• Registration Number: NCT01874613
• Lead Sponsor: Turku University Hospital

Brief Summary

Bioactive fibre-reinforced composite implant is used for reconstruction of skull bone defects and orbital floor defects.

Functional and aesthetic outcome is assessed by patient and doctor.

Detailed Description

Development phase: Clinical trial Objectives: Assessment of functional and aesthetic outcome Methodology: Intervention study Sample size: 35+20+25 Main criteria for inclusion: Skull bone defect OR orbital floor fracture

Investigational drug/treatment, dose and mode of administration: FRC implant Comparative drug(s)/placebo/treatment, dose and mode of administration: -

Duration of treatment: 2 years of follow-up

Assessments:

Clinical outcome and radiologic assesment Functional and aesthetic outcome with Visual Analog Scale (VAS). Pain assessment with VAS.

Statistical methods:

Adequate statistical methods for publishing in international peer-reviewed journals.

Study Timeline

• Study First Submitted: 2012-11-13
• Study Start: 2013-01
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-11
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-18
• Last Update Posted: 2015-02-19
• Primary Completion: 2016-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Study arm 1:

• patients with skull bone defect
• reconstruction indications fullfilled

Study arm 2:

• patients with orbital floor defect
• reconstruction indication fullfilled

Exclusion Criteria

• if informed consent cannot be obtained

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skull bone reconstruction	FRC implant reconstruction	Patients with skull bone defect
Orbital floor defect	FRC implant reconstruction	Patients with orbital floor defect

Primary Outcome Measures

Name	Time	Method
Functional outcome (a composition of following measures)	2 year follow-up	After reconstruction, patient follow-up protocol follows to assess functional outcome, including safety.; Follow-up is done at timepoints of 1 week, 1 month, 3 months, 6 months and after that every 6 month up to 2 years post-operatively. After this the follow-up is continued yearly, if necessary.; Visual and manual assessment is done by a doctor. Lateral and PA skull rtg is obtained to assess the fixation and position of the implant.; C-reactive protein level and leukocyte level is measured to assess the possible inflammation.

Secondary Outcome Measures

Name	Time	Method
Aesthetic outcome (a composition of following measures)	2 years post-operatively	After reconstruction, patient follow-up protocol follows to assess aesthetic outcome.; Follow-up is done at timepoints of 1 week, 1 month, 3 months, 6 months and after that every 6 month up to 2 years post-operatively. After this the follow-up is continued yearly, if necessary.; Visual and manual assessment is done by a doctor. Visual Analog Scale (VAS) is used by patient to assess; * functional outcome; * aesthetic outcome; * pain Lateral and PA skull rtg is obtained to assess the fixation and position of the implant.; C-reactive protein level and leukocyte level is measured to assess the possible inflammation.

Trial Locations

Locations (1)

Department of Otorhinolaryngology; 🇫🇮 Turku, N/A = Not Applicable, Finland